The renewal of European regulations regarding pharmaceutical process validation in autumn 2001 has been the subject of much discussion. The purpose of this article is to summarize and review the ...

In-silico design facilitates process optimization and evaluation of process control strategies. The pharmaceutical industry has recognized the value of implementing a systematic approach to drug ...

Design space optimization and flexibility analysis are central to enhancing the robustness, efficiency and regulatory compliance of pharmaceutical manufacturing. These approaches routinely combine ...

Technological innovations throughout the past several decades have transformed the pharmaceutical manufacturing process from traditional batch production to ...

The hot melt extrusion (HME) process can be employed in the production of a wide range of pharmaceutical dosage forms, including capsules, tablets, lozenges and implants. HME is suitable for both ...

Pharmaceutical process chemists are in a unique position to design and develop chemical processes that not only improve drug efficacy and safety but also are good for the environment and their company ...

The World Health Organization (WHO) defines an active pharmaceutical ingredient (API) as: “Any substance or combination of substances used in a finished pharmaceutical product (FPP), intended to ...

Pharmaceutical process chemists want to make the compound, the whole compound, and nothing but the compound. They know, however, that chemistry isn’t that simple and that a multistep synthesis often ...

Access to affordable medicines remains one of the most urgent public health and economic challenges across many African ...

The pharmaceutical industry is undergoing a paradigm shift, driven by cutting-edge technologies and new digital capabilities. This transformation, known as Pharma 4.0, is akin to the fourth industrial ...